In the pharmaceutical industry and especially in the field of perfusion solutions, impermeable flexible bags are extensively used. Such bags or containers are prepared from polymerized materials which have to meet a wide variety requirements. Thus, in particular, gas and vapor tightness, transparency, printability and inertness towards the substances they contain, are of essential importance. The substances contained in the containers or bags essentially consist of salts and solutions thereof, carbohydrates, amino acids and lipids. They are usually employed in multicompartment bags, the individual compartments or chambers being filled with different components.
DE 44 10 876 A1 relates to a multicompartment bag made of a polymeric material, who's bag compartments are formed by welds in the peripheral (circumferential) region and by at least one weld in the intercompartment region, the welds being formed from the polymeric materials facing the compartments.
EP 0 295 204 B1 describes a container for medical use, in particular a container for infusions consisting of an envelope made of a flexible, homogeneous, polymerized material which is divided into three compartments, separated from each other by leaktight welds of the envelope material and each of said compartments is provided with an occluded passage which can be opened deliberately to enable the contents of the part of the interior space to flow into another one, wherein the container has two adjacent compartments (3,4) of the interior space within the upper portion thereof and one compartment (5) in its lower part within the lower portion thereof and is intended for taking up and mixing subsequently lipids, amino acids, and sugars just before the use thereof, wherein each compartment is provided with one occludable opening in order to supply the compound through said opening or to discharge the contents thereof through said opening outwards, and wherein the material of the envelope is chemically and biologically inert against any envisaged compound and the mixtures thereof.
DE 94 01 288 U1 pertains a multichamber bag having at least two chambers being arranged one upon another during the mixing stage and being surrounded by an exterior boundary, said chambers being separated from another by at least one bar and forming an upper chamber and a mixing chamber, said bag having at least one connecting device being arranged within the bar and being closed by a locking device which is to be opened, said connecting device providing a flow connection between the chambers after being opened, said bag having at least one hang up opening at the upper boundary region and a discharge device being arranged at the mixing chamber as well as a second discharge device being opposite to said former discharge device and being arranged in the circumferential region of the mixing chamber.
DE 196 05 357 A describes a flexible plastic container 1 for the spatially separated storage and, optionally selective sterilization of the ingredients of preparations for parenteral or enteral use, comprising at least four compartments, 2,3,4, and 5, and, optionally, a compartment 6 being suited for taking up trace elements within compartment 2, carbohydrates within compartment 3, fats within compartment 4, and amino acid solutions within compartment 5, and, optionally, electrolytes and/or vitamins within compartment 6, said container having one of the closable fill in openings 7, 8, 9 and 10, and, optionally, 11, each; one discharge opening 12 for administering the mixture of ingredients of the preparations for parenteral or enteral use; connecting means 13, 13′, 14,14′ and 15, 15′ and, optionally, 16, 16′ which can be opened sterilely from the outside, by which flow connections between the compartments 2,3,4 and 5 and, optionally 6, respectively, can be provided; wherein the proportions by volume of compartments 2,3,4 and 5 and, optionally 6 are selected such that in the working position as resulting from suspending by hang up means 17 a complete mixture of all ingredients within compartment 5 is possible by opening the connecting means 13,13′, 14, 14′ and 15, 15′, and optionally 16, 16′; the proportion by volume of compartment 2 to compartment 3 is selected such that in the working position as resulting from suspending by hang up means 17 a complete mixture of the ingredients of compartments 2 and 3 within compartment 3 is possible by opening the connecting means 13, and, optionally, the proportion by volume of compartment 4 to compartment 6 is selected such that in the working position as resulting from suspending by hang up means 17 a complete mixture of the ingredients of compartments 4 and 6 within compartment 4 is possible by opening the connecting means 16, 16′.
EP 1 011 605 B2 relates to a flexible plastic container (1) for the spatially separated storage and, optionally, selective sterilization of the ingredients of preparations of parenteral or enteral use, consisting of only three compartments, a first compartment (3, a second compartment (4) and a third compartment (5), said compartments being separated from each other by means of Ieaktight welds of the envelope material, said compartments having one closable fill in opening (7), (8) and (9), each; connecting means (10) and (11) which are formed as peelable heat-sealed welds which can be opened sterilely from the outsides, by which respective flow connections between compartments (3), (4) and (5) are selected such that in the working position as resulting from suspending by the hang up means (12) a rapid and complete mixture of all ingredients within the third compartment (5) is possible by opening the connecting means (10) and (11), characterized in that the first compartment (3) contains carbohydrates, the second compartment (4) lipid and the third compartment (5) amino acids.
WO 2007/037793 A1 relates to a multiple chamber container for separately storing components of a parenteral nutritional formulation. The multiple chamber container may include frangible barriers, preferably peelable seals separating the chambers from each other. The container preferably facilitates the selective activation of the peelable seals to permit the admixing of less than all the separately stored components. The container may include a chamber positioned at each other of the opposite lateral ends of the container and at least one additional chamber between the lateral chambers. The at least one additional chamber may have a longitudinal length substantially less than the longitudinal length of at least one of the lateral chambers. This configuration allows for selective opening of the seals since when rolling the container from the top avoids pressurizing the at least one additional chamber and inadvertent activation of a seal. The longitudinal length of the at least one additional chamber may be from about two-thirds to about three-fourths the longitudinal length of at least one of the lateral chambers. Alternatively, the container may include a hanger flap extending from a top end of the container towards the bottom end of substantially greater distance relative to the at least one additional chamber than the lateral chambers.
EP 1 773 277 B1 relates to a container for storage a pharmaceutical agent made of a flexible polymeric film wherein the container comprises at least one peelable seal comprising at least two substantially straight sections (7,8), which are connected by a curved rupture zone (5), the curved rupture zone (5) of the peelable seal being formed as an arc of a circle having a central angle of at least 60° and being curved over its whole length between the straight sections (7,8), characterized in that the curved rupture zone (5) is formed as an arc of a circle with a radius of 5 to 75 mm, wherein the radius is measured from the central point of the circle to a point of the outer edge of the seal, wherein the outer edge is the edge that is more dislodged from the central point than the inner edge, and that the substantially straight sections (7,8) of the peelable seal form an angle of 150 ° to 180°.
WO 97/37628 relates to an improved container for parenteral fluids. Said publication in particular discloses a flexible transparent container for improved storage of oxygen sensitive parenterally administrable agents comprising an inner, primary container enclosed in a substantially oxygen impermeable outer envelope with an oxygen absorber, capable of consuming essentially all residual oxygen after the outer envelope is sealed, and for sufficient period also the oxygen penetrating said envelope. The inner container is made of a polypropylene containing flexible polymeric material compatible with lipophilic agents capable of forming both permanent and peelable seals, while the envelope is made of a substantially water impermeable flexible multilayered polymeric material comprising a first outer substantially water impermeable polymeric film with oxygen barrier forming capacity, assembled with a second, inner polymeric film with a supplementary oxygen barrier forming capacity. The container essentially maintains its characteristics after being subjected to sterilization by steam or radiation.
The peelable seams 50 and 50′ according to FIG. 1 have the shape of an inverse letter “V” with an increasing angle of the lines of said “V” from the basic point of said “V”. The inner container shown in FIG. 1 is a bag formed and provided with three parallel chambers 31,32,33 which may have the same or different volumes dependent on the desired amount the stored product. The two seams 50,50′ separating the chambers are typically formed by peelable seal weldings in the container which are highly tight, but possible rupture by a predetermined motion of the user. It is preferred herein to fill in the carbohydrates solution in the top chamber 31, whereas the middle chamber 32 contains the lipid emulsion while accordingly, the amino acid solution is designated to be filled in the lower chamber 33. Nevertheless, said construction cannot ensure even in case of an abuse of the nurse, that in a first instance the incompatible lipid emulsion and the carbohydrate solution is mixed prior to the admixture of the amino acid. Furthermore, the rectangular termination of the welding seams 50,50′ to the circumferential weld may result in a dead volume in the corners of said connection.
The core of this patent is a curved rupture zone 5 being formed as an arc of a circle with a defined radius. However, since the peelable seals 41, 32 and 33 extend to the lower weld 25, there always exist a dead volume and thus, the content of the container cannot be used for complete administration to the patient. Similarly, the rupture zone 39 in FIG. 3 of EP 1 773 277 B1 does not ensure a complete usage of the material contained in the bag.
Thus, it is the aim the present invention to simplify the final structure of a flexible multiple chamber bag 10 for storing medical products and to improve the use thereof by the nurse. Furthermore, it should be ensured, that the ingredients, namely fat and amino acids are first mixed before adding the glucose or carbohydrate. Thus, the object of the invention in particular is to avoid a first mixture of glucose and fat independent from any potential abuse of the bag by the nurse.